Def of Forensic Pharmacy by Fatima

1
Basic definitions of Pakistan

forensic pharmacy (Drug law)
Prepared by:
Dr.Fatima Arain
Pharm-D
Hospital/clinical pharmacist
The university of Faisalabad pakistan
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Act:
The formal decision of law of legislative body.

Or
It is an enactment made by binding by the sanction of official authority.
Adulterated Drugs:
Adulterated drugs means a drug

(i) which consists in whole or in part of any filthy, putrid or decomposed substance
or which contains any foreign matter, vermin, worm, rodent or insect;
Or
(ii) which has been manufactured, packed, or held under unsanitary conditions
whereby it may have been contaminated with dirt, filth or any other foreign matter
or whereby it may have been rendered injurious to health;
Or
(iii) The container of which releases any poisonous or deleterious substance which
may render the contents injurious to health;
Or
(iv) Which bears or contains as an ingredient a substance other than the prescribed
substance
Or
(v) With which any substance has been mixed or packed so as to reduce its quality
or strength or for which any substance has been substituted wholly or in part.
Appellate Board
The Board for the disposal of appeals preferred by persons aggrieved by any
decision of the central licensing board or the registration board or the Licensing
Authority or a Board or
Batch:
Batch means a quantity of any drug produced during a given cycle of manufacture.
Batch Number:
Batch number means a designation printed on the label of a drug that identifies the
batch and permits the production history of the batch, including all stages of
manufacture and control, to be traced and reviewed.
Counterfeit Drug:
Counterfeit drug means a drug the label' or outer packing of which is an imitation
of, or resembles or so nearly resembles as to be calculated to deceive the label or
outer-packing of a drug of another manufacture.
Drug:
Drug includes-1. Any substance or mixture of substances that is manufactured, sold, stored,
offered for sale or represented for internal or external use in the treatment,
mitigation, prevention or diagnosis of diseases, an abnormal physical state, or
the symptoms thereof in human beings or animals or the restoration,
2.
3.
4.
5.
6.
7.
8.
correction, or modification of organic functions in human beings or animals,

not being a substance exclusively used or prepared for use in accordance with
the ayurvedic, unani, homoeopathic or biochemic system of treatment except
those substances and in accordance with such conditions as may be
prescribed,
Abortive and contraceptive substances, agents and devices, surgical ligatures,
sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive
plasters, gelatine capsules and antiseptic solutions,
Such substances intended to be used for the destruction or repulsion of such
vermin, insects, rodents and other organism as cause, carry or transmit
disease in human beings or animals or for disinfection in residential areas or in
premises in which food is manufactured, prepared or kept or stored,
Such pesticides as may cause health hazard to the public,
Any substance mentioned as monograph or as a preparation in the Pakistan
Pharmacopoeia or the Pakistan National Formulary or the International
Pharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical
Codex or the United States Pharmacopoeia or the National Formulary of the
United States, whether alone or in combination with any substance exclusively
used in the unani, ayurvedic, homoeopathic or biochemical system of
treatment, and intended to be used for any of the purposes mentioned in subclauses (i), (ii) and (iii), and,
Infant formulas, follow up milks, milk substitutes, baby foods , baby gruels ,
baby teas and juices , bottles and teats and any other product used as infant
formula as such,
Cosmetics including hair sprays , perfumes, facial and talcum powders, hair
treatment shampoos, hair conditioning aids and devices and all formulas and
lotions connected therewith for conditioning and cleansing of hair , hair
colours, facial makeup foundations ,vanishing and cold creams, creamy
makeup sticks, bath lotions and oils, blushers and blush-ons , texture
improvement devices, moisturisers of all kinds, mascaras, vaselines , surmas,
wrinkle care creams, hair oils/ herbal preparations for texture and facial glow
and improvement, shower creams ,skin lotions and oils, sunburn lotions and
oils, shaving cream and lathers , after shave lotions ,and any other
preparation or material connected therewith,
Any other substance which the Federal Government may, by notification in the
official Gazette, declare to 'be a "drug" for the purposes of this Act.
The Drugs Act
An Act to regulate the import, export, manufacture, storage, distribution and sale of
drugs.
Expiry Date:
Expiry date means the date stated on the label of a drug after which the drug is not
expected to retain its claimed efficacy, safety, quality or potency or after which it is
not permissible to sell the drug.
Expert:
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Expert means a specialist through university education and experience in the
relevant field.
Export:
Export with its grammatical variations and cognate expressions, means to take out
of Pakistan by sea, land or air.
Forensic Pharmacy
Forensic Pharmacy is the foundation of the structure on which the sacred profession
of Pharmacy has been built up in our Country. It provides much needed legal
support, professional backing and ethical strength for the systematic growth of the
profession. Pharmacist as a drug custodian, drug maker, drug counsellor, drug
dispenser, drug analyzer, and drug educator has to discharge his duties within the
orbit of professional discipline. The profession devices its strength from the legal
provisions such as, Acts, Rules, Bill, Orders, and Statutes covered in Forensic
Pharmacy, also known as Pharmaceutical Jurisprudence.
Generic Name:
Generic name means the non-proprietary, scientific or official name of a drug as

approved by the Federal Government.
Government Analyst:
The persons appointed by Federal Government or a Provincial Government may, by

notification in the official Gazette, as it thinks fit, having the prescribed
qualifications, to be the Federal Government Analysts or, as the case may be,
Provincial Government Analysts, for such areas and in respect of such drugs or
classes of drugs as may be specified in the notification.
Investigator:
Investigator means a person engaged in the investigation, research, development

or evaluation of a drug on his own initiative or under the sponsorship of any other
person or an institution.
Import:
Import with its grammatica1 variations and cognate expressions means to bring
into Pakistan by sea, land or air.
International Non-Proprietary Name:
Means the name of a drug as recommended by the World Health Organization or

such other name as may be notified by the Federal Government in the official
Gazette.
Jurisprudence
The science and knowledge of law.

Label:
Label means a display of written, printed or graphic matter upon the immediate
container, or the outside container or wrapper of a drug package.
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Labelling:
Labelling means all labels

accompanying any drug.
and
other
written,
printed
or
graphic
matter
Licensing Authority:
Licensing authority means such authority as may be prescribed.

Manufacture:
Manufacture in relation to a drug, means all operations involved in the production

of the drug, including processing, compounding, formulating, filling, packing,
repacking, altering, ornamenting, finishing and labelling with a view to its storage,
sale and distribution, but does not include the compounding and dispensing or the
packing of any drug in the ordinary course of retail business or on a prescription of
a registered medical practitioner or dentist or of a veterinarian and "to
manufacture" shall be construed accordingly.
Misbranded Drug:
Misbranded drug means a drug

(i) Which is not labelled in the prescribed manner; or
(ii) on the label or labelling of which any word, statement or other matter or
information required by the rules to appear on the label or labelling is not
prominently placed with such conspicuousness (as compared with other words,
statements, designs, or devices on the label or labelling) and in such terms as may
render it likely to be read 'and understood by the ordinary individual under
customary conditions of purchase and use; or
(iii) which is not labelled with such directions for use and such warnings against use
in indications where its use may be dangerous to health, or against unsafe dosage
or duration of administration or application in such manner and form as are
necessary for the protection of users or as may be prescribed; or
(iv) the label or container of which, or anything accompanying which, bears any
statement, design or device which makes any false claim for the drug or which is
false or misleading in any particular; or
(v) which is so coloured, coated, powdered or polished that damage is concealed, or
which is made to appear of better or greater therapeutic value than it really is; or
(vi) Which is manufactured according to the specifications of a particular
pharmacopoeia or any other document as may be prescribed and the label does not
bear the name of that pharmacopoeia or document.
Ordinance:
Something ordered by person(s) in authority; a law.

Pharmacopoeial Name:
Means the name of a drug as mentioned in any pharmacopoeia.

Policy:
Declaration of intent in which the Government commits itself, on the basis of a

number of values and principles, to achieve a number of objectives to resolve
specific problems of the sector by implementing appropriate strategies. Any policy
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should set the goals, objectives and strategies required to resolve the major
problems identified in the sector.
Preamble:
Preface, introduction especially that of an act of parliament giving its measures and
purposes.
Pakistan National Formulary:
The Federal Government shall compile and publish in the official Gazette Pakistan
National Formulary comprising all drugs allowed to be imported, manufactured or
sold and such Formulary may be reviewed and modified from time to time.
Rule:
1. Denotes an instruction for enforcing discipline, uniformity, and order in

relation to an activity.
2. It is a fix principle or direction, regulating behavior, procedure or action.
3. A code of regulation, a guiding principle a method or process of achieving a
result of control.
Regulate:
To control by rules; to keep in order.

Recipient:
Means a person or an institution who or which receives aid from the Fund
Registered Medical Practitioner:
Means a medical practitioner registered or provisionally registered under the

Medical and Dental Council Ordinance, 1962.
Regulation:
Regulation is an authoritative, directive or order intended to control behavior or

procedure governing rule or law.
Or
A rule or order which is prescribed by controlling authority.
Sell:
Sell means sell, offer for sale, expose for sale, and have in possession for sale and
distribution and "to sell", "sold" or "sale" shall be construed accordingly.
Specifications:
Specifications when applied to a drug mean

(i) such specifications as may be prescribed; or
(ii) when the specifications are not prescribed, the specifications as contained in the
most recent edition of any of the following publications, namely:(1) the Pakistan Pharmacopoeia;
(2) the International Pharmacopoeia;
(3) the European Pharmacopoeia;
(4) the United States Pharmacopoeia;
(5) the British Pharmacopoeia;
(6) the British Pharmaceutical Codex;
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(7) the United States National Formulary; and
(8) such other publication as may be prescribed:
Provided that, if the specifications do not appear in the most recent edition of any
such publication, the specifications appearing in the next preceding edition of such
publication in which the specifications appear shall apply; or
(iii) If no specifications are either prescribed or contained in any of the publications
referred to in sub-clause (ii), the specification approved for the purpose of
registration under this Act.
Spurious Drug:
Spurious drug means a drug-(i) which purports to be a drug but does not contain the active ingredient of that
drug; or
(ii) Which purports to be the product of a manufacturer, place or country of whom
or of which it is not truly a product; or
(iii) Which is imported or exported or sold or offered or exposed for sale under a
particular name while actually it is another drug; or
(iv) The label of which bears the name of an individual or company purporting to be
its manufacturer or producer which individual or company is fictitious or does not
exist.
Storage:
Storage means storage for sale and "to store" or "stored" shall be construed
accordingly.
Statute:
A written law expressly enacted by the legislature (law making body)

Sub-Standard Drug:
Sub-standard drug means a drug which is not of specifications.

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1

Basic definitions of Pakistan

The formal decision of law of legislative body.

Adulterated drugs means a drug

correction, or modification of organic functions in human beings or animals,

The Drugs Act

Generic name means the non-proprietary, scientific or official name of a drug as

The persons appointed by Federal Government or a Provincial Government may, by

Investigator means a person engaged in the investigation, research, development

Means the name of a drug as recommended by the World Health Organization or

The science and knowledge of law.

Labelling means all labels

Licensing authority means such authority as may be prescribed.

Manufacture in relation to a drug, means all operations involved in the production

Misbranded drug means a drug

Something ordered by person(s) in authority; a law.

Means the name of a drug as mentioned in any pharmacopoeia.

Declaration of intent in which the Government commits itself, on the basis of a

1. Denotes an instruction for enforcing discipline, uniformity, and order in

To control by rules; to keep in order.

Means a medical practitioner registered or provisionally registered under the

Regulation is an authoritative, directive or order intended to control behavior or

Specifications when applied to a drug mean

A written law expressly enacted by the legislature (law making body)

Sub-standard drug means a drug which is not of specifications.

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